Platelet-Directed Whole Blood Transfusion Strategy for Malaria

NCT05711485 | Recruiting DMC

• 1 other identifier: IRB00015011
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 2

Brief Summary

Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

Conditions

Severe Malaria; Thrombocytopenia

Keywords

Malaria; Plasmodium falciparum; Zambia

Outcome Measures

Primary Outcomes (1)

• Incidence of all-cause mortality

  Death due to any cause

  Up to hospital discharge or in-hospital death, up to 28 days on average

Secondary Outcomes (6)

• Change in hemoglobin (Hb)

  Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later

• Change in platelet count

  Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later

• Change in white blood cell (WBC) count

  Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later

• Incidence of transfusion reaction

  During or after transfusion, up to the day of hospital discharge or in-hospital death, up to 28 days on average

• Length of hospitalization

  Up to hospital discharge or in-hospital death, up to 28 days on average

Study Arms (2)

Whole blood transfusion

EXPERIMENTAL

Whole blood transfusion x1 (20 mL/kg)

Other: Whole blood transfusion

Control

NO INTERVENTION

Standard-of-care

Interventions

Whole blood transfusion OTHER

Whole blood is sourced from the Zambia National Blood Transfusion Service.

Whole blood transfusion

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \<5 years
• Platelet count ≤75,000/uL
• Hemoglobin \>5 and ≤9 g/dL
• P. falciparum parasitemia ≥500 parasites/uL
• Diagnosis of severe malaria meeting World Health Organization (WHO) criteria
• Ability and willingness of the legal guardian to comply with study protocol for the duration of the study
• Residence within health clinic catchment area
• Signed informed consent obtained from the parent or legal guardian of the participant

You may not qualify if:

• Residence in foster care or children otherwise under government supervision
• Residence outside the hospital catchment area, or plan to leave the area
• Presence of any other condition or abnormality which, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data
• Any contraindication to whole blood transfusion

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Johns Hopkins University: collaborator
• Tropical Diseases Research Centre: collaborator
• University of California, San Francisco: collaborator
• University of Maryland: collaborator

Study Sites (2)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

Tropical Diseases Research Centre

Ndola, Copperbelt, Zambia

RECRUITING

Related Publications (1)

• Ippolito MM, Kabuya JB, Hauser M, Kamavu LK, Banda PM, Yanek LR, Malik R, Mulenga M, Bailey JA, Chongwe G, Louis TA, Shapiro TA, Moss WJ; Southern and Central Africa International Centers of Excellence for Malaria Research. Whole Blood Transfusion for Severe Malarial Anemia in a High Plasmodium falciparum Transmission Setting. Clin Infect Dis. 2022 Nov 30;75(11):1893-1902. doi: 10.1093/cid/ciac304.

  PMID: 35439307 BACKGROUND

MeSH Terms

Conditions

Malaria; Thrombocytopenia; Malaria, Falciparum

Interventions

Exchange Transfusion, Whole Blood

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Matthew M Ippolito, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew M Ippolito, MD PhD

CONTACT

443-287-4809; mippolito@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 3, 2023
• Study Start: February 24, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Approx. 1-2 years after data collection

Locations

US (1); ZA (1)